Injection device

ABSTRACT

A transcutaneous injector having an integral sealing means for cooperation with a protective cover to facilitate aseptic storage of biological substances. The cup-shaped cover is provided with vent ports for accomplishing a vacuum before the injector is fully positioned within the cover interior. A resilient flange annularly attached to the injector selectively effects a seal with the cover or allows communication of the vent ports to the interior of the cover.

United States Patent Inventor Robert Richard Malone [56] References Cited 915mm, UNITED STATES PATENTS P 3,221,739 12/1965 116561111161 128/253 :3 3,246,647 4/1966 Taylor et a1 128/253 2 5: iiisir isrom w 1 c 3,322,121 5/1967 Banker 128/253 CM m n FOREIGN PATENTS 1,309,352 10/1962 France 138/253 Primary ExaminerRichard A. Gaudet Assistant Examiner-J. C. McGowan Att0rneys-Robert W. Beart, Michael Kovac, Barry L. Clark and Jack R. Halvorsen INJECTION DEVICE 3 cums 5 Figs ABSTRACT: A transcutaneous injector having an integral US. Cl 128/253, sealing means for cooperation with a protective cover to 128/172, 206/634, 128/215 facilitate aseptic storage of biological substances. The cuplnt. Cl A61b 17/20, shaped cover is provided with vent ports for accomplishing a 5 A6 1 m 5/00 vacuum before the injector is fully positioned within the cover Field of Search 128/253, interior. A resilient flange annularly attached to the injector 172, 173, 272, 218, 302, 303, 213, 215, 216; selectively effects a seal with the cover or allows communica- 215/56, 47; 206/56, 62, 63 tion of the vent ports to the interior of the cover.

I I 20 I l 1 so 22/ 44 3o INJECTION DEVICE BACKGROUND OF INVENTION lntracutaneous injections have been and currently are being used in the practice of medicine for a variety of diagnostic, prophylactic and therapeutic purposes. Fluids, greases, ointments, powders, crystals and the like containing or composed of allergens, which are materials capable of eliciting an allergic reaction, as well as vaccinia-virus type products, which are materials capable of eliciting a vesiculopustular lesion, and, in addition, toxins, antitoxins, toxoids, sera and the like, are placed in abraded or scratched skin areas, driven into the skin by means of skin puncturing devices, or, in those instances where the materials are in a fluid state, injected intracutaneously by means of a syringe and needle arrangement to accomplish a diagnostic reaction or a prophylactic or therapeutic treatment.

The use of a syringe and needle or purpose of an intracutaneous injection is expensive and requires a degree of skill and experience to insure that the dosage is correct and is injected properly in an intradennal position. The cost of repeated sterilization as well as the possibility of contamination which could result in the occurrence of false tests, as well as the transmission of blood-borne diseases from person to person, make the syringe and needle approach highly undesirable in treatment of large groups such as military forces, native populations, victims in a disaster area and the like. Other approaches which have been utilized are the placement of a biologically active material percutaneously, upon the intact skin, followed by use of a multiple puncture device having a vertical stabbing action to carry the material through the skin surface and thus administer a transcutaneous or intracutaneous injection. These involve the problems of contamination of the material on the device as well as insuring that the skin surface is sterile prior to application of the material to the surface. Multiple prong devices of this type are old in the art and can be readily seen in the U.S. Pat. Nos. 2,619,962; 2,893,392; 3,072,122; and 3,221,740.

The use of disposable injection devices having a dried or lyophilized biological substance present on the ncedlelike projections for transcutaneous introduction into the body are known to the art; however, most such devices are limited to the use of a fully attenuated or deal vaccine, thereby limiting their usefulness.

SUMMARY The present device contemplates the use of live attenuated vaccines which are maintained within the confines of a closed device capable of preserving a vacuumlike condition which is desirable in the preservation of the vaccine.

The present device contemplates an improved injection device which includes a rigid backing member of synthetic material adapted to be held in the fingers; a thin metal plate secured to the backing member including a plurality of needlelike projections punched from the metal plate and projecting from one side thereof; an attenuated vaccine, which can be in liquid form, dried, or lyophilized, and later activated by a diluent, being present on the ncedlelike projections for transcutaneous introduction into the body; and a substantially rigid imperforate protective cover removably secured to the backing member and covering the metal plate for protecting the ncedlelike projection and the biological substance thereon from contamination prior to use. Lastly, the device includes an integral sealing means which preserves a substantial vacuum between the protective cover and the backing member and is maintained in sealing position by the atmospheric pressure acting against the external surface of the sealing member to insure that the unit is self-sealing.

An important object of the present invention is to provide a low-cost injection device for use where cost is a factor, such as in mass testing of patients or in multiple injections conducted on individuals.

A further object of the present invention is to provide an injection device which will maintain the purity of the biological substances being injected.

Another object of the invention is to provide an injection device which is capable of being utilized for the storage of live attenuated vaccines in a partial vacuum condition.

These and other objects of the invention will be apparent to those skilled in the art on reference to the specification to the attached drawing illustrating a preferred embodiment of the invention in which like parts are identified by like numerals in each of the views, in which:

FIG. I is a perspective view of an embodiment of the injection device contemplated by the present invention;

FIG. 2 is an elevational view in partial section of the embodiment shown in FIG. 1 prior to assembly;

FIG. 3 is an elevational view in partial section showing the device in FIG. 2 after assembly;

FIG. 4 is an enlarged fragmental sectional view of the device shown in FIG. 2 during evacuation; and

FIG. 5 is an enlarged fragmental section similar to that of FIG. 4 after the device has been seated and sealed.

DESCRIPTION An injection device 10 of the type contemplated by this invention includes a holder 12, a metallic plate 14 carrying the injection tines l6 and a cover means 18.

The holder 12 in thepr'esent device is an elongated hollow cupshaped member having a handle portion 20 with external splines 21 for improved gripping and a rigid end 22. Plate 14 is provided with a plurality of prongs or tines 16 extending from one side of plate 14 while the other side is mounted in juxtaposed relation to end 22. The assembly of plate 14 with end 22,-in this embodiment, is accomplished by a plurality of postlike protuberances 24 which are telescopically assembled through a similar number of apertures in plate 14 and then upsetor deformed-to create-enlarged heads 26 which overlie the plate 14 and maintain it in assembled relation to holder 12. Other forms of assembly which accomplish the mounting and rigidification of plate l4'are equally acceptable.

Intermediate the extremities of the elongated ribbed handle portion 20 is a laterally extending flange 28 forming a downwardly facing shoulder 30, as viewed in the drawing. Extending upwardly from the outer periphery of flange 28 is a continuous resilient'umbrellalike sealing member 34 which terminates in an axially extending annular portion 36, for pur poses best set forth hereinafter.

The cover 18 is a cup-shaped device open at one end and closed at the other. It includes a base 40, which may be reinforced by one or more ribs 41 which extend out to the edge, and has an integral peripheral sidewall 42 with a predetermined thickness. The sidewall 42 at its open end has a coun-- terbore 44 which provides an intermediate shoulder 46 facing the open end of cover 18. At the closed end an external flange 47 is provided for gripping means.

The holder 12 is adapted to be telescopically associated with the cover I8. The dimensional relationships of the two parts are controlled so that when the shoulder 30 bottoms on the shoulder 46, the tines 16 will be spaced a substantial distance from the base 40 and its associated ribs 41 so that even if the holder 12 is inserted in a skewed relation, the tines will not be disturbed or bent. The diameter of flange 28 is controlled so that it is substantially less than the internal diameter of the counterbore 44 but larger than the internal diameter of sidewall 42. The-diameter of sealing flange 34 at its outer extremity, as defined by the axial cylindrical portion 36, is substantially greater than the internal diameter of counterbore 44. The annular portion 36 tends toprovide hoop strength and gives a uniformity of configuration to the sealing flange 34 as it is resiliently bent when brought into contact with the counterbore 44. The portion 36 insures that the flange 34 does not become wrinkled or corrugated inconfiguration as it is bent. Additionally, the'angularity and radial extent of flange 34 is controlled so that it contacts the inner comer 50 of the upper end of counterbore 44 prior to the seating of shoulder 30 against shoulder 46 to insure that substantial portion of flange 34 will be disposed in intimate axially directed contact with the sidewall 44.

The plate, generally is a think sheet of stainless steel which will not contaminate nor be contaminated by any of the vaccines or antigens to be placed thereon and generally has a rectangular configuration with a plurality of sharply pointed needlelike projections 16 punched from the central portion of the plate. The tines or needlelike projections 16 are preferably of unifonn length and size and project at right angles from the plane of the thin metal plate 14 from 1 to about 4 mms., depending upon the type of vaccination to be accomplished. The holder 12 and the cover 18 are preferably formed of suitable, substantially rigid, moldable, plastic materials which are capable, when the thickness of the material is controlled, of providing resilient sections integrally affixed to the rigid portion, as for example the resilient sealing flange 34 attached to the rigid flange 30 and holder 12. The members 12 and 18 may be suitably molded from plastic materials such as polyethylene, polycarbonate, modified polyphenylene oxide and polysulfone.

In preparing the packages, the metal plates 14 are cleaned and the needlelike projections 16 thereof are thereupon coated with the desired wet antigenic or allergenic or immunizing or testing substance by merely dipping the projection into a liquid solution of the substance or by cataphoresic or electrophoresic deposition of the substance upon the projection. The projections are then removed from the solution and the antigenic or similar substance is then dried upon the projection. In the case of most nonviable antigens, this drying may be carried out in the air at about 37 C. In the case of viable antigens, however, it is preferable to freeze-dry or lyophilize the substance upon the projection. In so doing, the wet substance is first frozen upon the projection by lowering the temperature to as much as -45 C., whereupon the metal plate with the frozen material thereon is placed in a vacuum chamber and left there for from 7 to l8 hours while the temperature is permitted to rise gradually to about 20 C.

The thin metal plate 14 with the dried antigenic substance upon the projection 16 thereof, is then secured in backed-up position upon the rigid end 22 by deformation of the protuberance 24 to form the head 26. It should be noted, however, that where the plastic material forming the holder 12 has the proper physical characteristics to withstand the depressed temperatures utilized in the lyophilizing of the antigen, the plates 14 may be affixed to the holders prior to application and lyophilizing of the antigens, When the antigenic substance on the projection 16 is of a nonviable type, the assembled plates 14 and holders 12 are then appropriately sterilized, as by steam or ethylene oxide or by any other suitable sterilizing compound. When the antigenic substance is of a viable type, on the other hand, sterilization must be accomplished before the substance is applied to the projection 16.

In the case of the nonviable types, the cover 18 and the holder 12 are axially telescoped together with the flange 34 deflecting upwardly against the counterbore wall 44 until the shoulder is seated in the inner shoulder 36 as best seen in FIG. 3. The frictional cooperation of the flange 34 and portion 36 with the sidewall of counterbore 44 will retain the cover 18 in place and effectively seal the prepared plate 14 so as to protect the coated projections 16 and prevent contamination of the substances thereon. In certain instances it is desirable to fill the volume with an inner atmosphere such as nitrogen or ethylene oxide so as to purge the package of the common gases of the atmosphere.

It has been found, further, that it is desirable in certain cases of lyophilized viable antigens to maintain them in a vacuum even after the process of lyophilization has been completed. In that instance, the present device is ideally adapted to maintain such a seal. When the antigen has been applied to the needles 16, the sterilized cover 18 and the holder 12 are brought together to a position such as that shown in FIGS. 2 and 4. It has been found desirable, in certain circumstances, to provide one or more vent ports 52 in the form of channels adjacent the upper edge 50 of the cover as seen in FIGS. 4 and 5. This permits the sealing flange 34 to make its initial contact with the edge 50 and yet allows the total evacuation of the internal chamber of the cover 18, as illustrated by the arrows passing through the port 52 in FIG. 4. When the desired level of vacuum has been reached by evacuation, the cover 18 and holder 12 are axially telescoped to the position shown in FIG. 5 where the shoulder 30 comes to rest on the shoulder 46 of the cover with the flange 34 intimately juxtaposed the counterbore wall 44. It can be readily appreciated that when the apparatus within which the vacuum has been applied is restored to atmospheric conditions, the atmospheric pressure will now act against and insure a positive seating of shoulder 30 on shoulder 46 as well as the pressure acting against the flange 34 and the opened portion of end 22, accessible through the handle 20, to further insure the sealing of the holder 12 relative to the cover 18.

When it is desired to effect a vaccination or skin test innoculation with one of the present packages, the package having the appropriate dried antigenic or biological substance on the projection 16 therein is selected. The skin of the patient is sterilized by alcohol or the like and the cover of the package is then removed. The removal of the cover is facilitated by pressing the outside wall between the fingers to distort it to an oval shape thereby tending to break the seal of the flange 34 and to restore atmospheric pressure internally of the chamber formed by the cover 18. Once the cover 18 has been removed from the package, the handle 20 is held in the fingers and the sharp-pointed coated projections 16 are pressed into the skin of the patient in the fashion known in the art. It will be appreciated that during the penetration of the projection into the skin, the rigid end 22 backs up or supports and tends to rigidify the thin metal plate 14 so that, despite its thin guage, there is little or no bending of the plate, with the result that all of the projections 16 may penetrate to a substantially uniform depth predetermined by the length of the projection. When a projection 16 has penetrated to the desired depth, the holder 12 is then held in this position for a few moments by the operator until the lymph and other body fluids in the deeper recesses of the skin dissolve the dried antigenic or biological substances from the points of the projection 16. With the backing member held as just described, the backing member is gripped between the thumb and fingers and is preferably given a gentle rotary motion, while the projections 16 are still embedded in the skin. This tends to insure that all of the antigenic or biological substance is removed from the projection and deposited in or beneath the skin. The vaccination will then have been completed, and the holder 12 with the metal plate 14 still intact thereon may then be removed from the patients skin and discarded.

It will be similarly appreciated that the cover 18 can serve a secondary function, namely, to permit the usage and storage of viable liquid biological substances in a partial vacuum stored condition. The differential in pressures between the interior of cover 18 and the atmospheric pressure will tend to maintain a positive seal between the holder 12 and the cover 18 whereby viable substances, which heretofore could not be stored due to the possibility of contamination of surrounding materials, can now generally be handled.

When certain types of plastic materials are utilized, it is conceivable that either a lining or overlayer of metallic foil material, not shown, will be necessary to insure maintenance of the vacuum and aseptic conditions. Similarly the present invention contemplates the possibility of utilizing a tear-tab, not shown, at one or more positions, either on the thinner portions of the cover 18 or on the sealing flange 34, to relieve the differential pressure for facilitation of removal.

It will readily be appreciated that the present packages may be easily reproduced in great number and, when effectively sealed as described above, may be stored for substantial periods at various places about the country and may be supplied to physicians in normal channels of trade, as is the case with ordinary medical supplies.

It will be apparent various additional changes and modifications may be made in the construction and arrangement of the components of this package within the spirit and scope of the invention, and it is intended that such changes and modifications be included within the scope of the appended claims.

I claim:

1. A transcutaneous injector package having a holder, a metal plate and a cover, said holder being thimble shaped and including a substantially rigid end, said end having means cooperating with and mounting said metal plate thereon, an upstanding sidewall having gripping means to permit said sidewall to act as a handle, said metal plate including a plurality of needlelike protuberances extending in a single direction away from said plate and means on said plate for cooperation with said end to mount said plate, said cover being hollow and cup shaped with one open and one closed end with a substantially continuous inner wall, means on said holder cooperating with means on said cover to limit the entry of said holder into said cover, integral sealing means on said holder including an inverted continuous umbrellalike resilient flange extending axially and outwardly along said handle away from said plate, said inner wall having a predetermined diametral measurement, said flange having a substantial axial extent with diametral measurements less than said predetermined measurement at its juncture with said handle and greater than said predetermined measurement at its free end so that a substantial portion of said flange is deflected radially inwardly and engages the inner wall of said cover, said flange being adapted to more aggressively engage said inner wall of said cover when the interior of said cover is evacuated and a differential in pressure exists between ambient conditions and the interior of said cover.

2. An injector of the type claimed in claim 1 wherein said cover includes vent port means to aid in evacuation of said cover but which are inoperative when said holder is seated relative to said cover 3. An injector of the type claimed in claim 1 wherein said flange is generally frustoconical in configuration which terminates in an axially extending annular portion having an external diametral measurement greater than said predetermined measurement. 

1. A transcutaneous injector package having a holder, a metal plate and a cover, said holder being thimble shaped and including a substantially rigid end, said end having means cooperating with and mounting said metal plate thereon, an upstanding sidewall having gripping means to permit said sidewall to act as a handle, said metal plate including a plurality of needlelike protuberances extending in a single direction away from said plate and means on said plate for cooperation with said end to mount said plate, said cover being hollow and cup shaped with one open and one closed end with a substantially continuous inner wall, means on said holder cooperating with means on said cover to limit the entry of said holder into said cover, integral sealing means on said holder including an inverted continuous umbrellalike resilient flange extending axially and outwardly along said handle away from said plate, said inner wall having a predetermined diametral measurement, said flange having a substantial axial extent with diametral measurements less than said predetermined measurement at its juncture with said handle and greater than said predetermined measurement at its free end so that a substantial portion of said flange is deflected radially inwardly and engages the inner wall of said cover, said flange being adapted to more aggressively engage said inner wall of said cover when the interior of said cover is evacuated and a differential in pressure exists between ambient conditions and the interior of said cover.
 2. An injector of the type claimed in claim 1 wherein said cover includes vent port means To aid in evacuation of said cover but which are inoperative when said holder is seated relative to said cover.
 3. An injector of the type claimed in claim 1 wherein said flange is generally frustoconical in configuration which terminates in an axially extending annular portion having an external diametral measurement greater than said predetermined measurement. 